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Senior Statistical Programmer Fsp

6+ years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Statistical Programmer FSP
Location: Remote, India
Job Type: Full-time
Posted: Feb. 14, 2025
Job ID: 442

Position Overview:

As a Senior Statistical Programmer, you will be fully embedded with one of Cytel’s pharmaceutical clients. You will use your advanced SAS programming skills and knowledge of CDISC standards (SDTM & ADaM) to support and potentially lead Phase I-IV clinical trials. This role can be performed remotely, providing an exciting opportunity to contribute to innovative drug development.

Responsibilities:

  • Perform data manipulation, analysis, and reporting for clinical trial data (both safety and efficacy), utilizing SAS programming.

  • Generate and validate SDTM and ADaM datasets, analysis files, and tables, listings, and figures (TLFs).

  • Ensure the production and QC/validation of programming outputs.

  • Create complex ad-hoc reports utilizing raw data.

  • Provide support for Efficacy analysis.

  • Review and create submission documents and eCRTs.

  • Communicate with cross-functional teams and clients regarding project specifications, status, issues, or inquiries.

  • Lead projects when necessary, handling multiple tasks and priorities.

  • Demonstrate flexibility when priorities change and ensure timely results.

Qualifications:

  • Education: Bachelor’s degree in Statistics, Computer Science, Mathematics, or related field. A Master’s degree is preferred.

  • Experience:

    • At least 8 years of SAS programming experience with clinical trial data in the pharmaceutical or biotech industry (with a Bachelor’s degree) or 6 years with a Master’s degree.

    • Study lead experience is preferred.

    • Strong expertise in SAS data manipulation, analysis, and reporting.

    • Experience implementing CDISC SDTM/ADaM standards.

    • Strong QC/validation skills and proficiency in ad-hoc reporting.

    • Familiarity with drug development lifecycle and clinical trial data.

    • Experience with immunology, respiratory, or oncology studies is a plus.

  • Skills:

    • Excellent analytical and troubleshooting abilities.

    • Ability to meet challenging deadlines and produce high-quality deliverables.

    • Experience with regulatory submission documents (define.xml).

Additional Information:

  • Location: Remote India).

  • Cytel is committed to staff development, encouraging innovation, collaboration, and the pursuit of discovery in clinical trials.

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